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FDA 510(k)

InMode RF System

K-Number: K163190 · 2016-12-12

ApplicantInmode MD , Ltd.
Decision Date2016-12-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

InMode RF System is a medical device manufactured by Inmode MD , Ltd.. It received FDA 510(k) clearance on 2016-12-12 under approval number K163190. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InMode RF System?

InMode RF System is a medical device that received FDA 510(k) clearance on 2016-12-12. It is manufactured by Inmode MD , Ltd.. The 510(k) number is K163190.

When was InMode RF System approved by the FDA?

InMode RF System received FDA 510(k) clearance on 2016-12-12, under approval number K163190.

What company makes InMode RF System?

InMode RF System is manufactured by Inmode MD , Ltd..

What is the FDA product code for InMode RF System?

The FDA product code for InMode RF System is GEI.

Other Devices by Inmode MD , Ltd.

K160329InMode System MiniFX Handpiece K153568InMode Plus System K151793InMode RF System K151273InMode FRF Applicator K172302InMode PLUS System K171593InMode RF System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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